Real-time Identification of the Aberrant Left Hepatic Arterial Territory in the Liver Using Near-infrared Fluorescence Imaging

Stomach Neoplasm Clinical Trial

Official title:

Real-time Identification of the Aberrant Left Hepatic Arterial Territory in the Liver Using Near-infrared Fluorescence Imaging: Prospective Study to Develop Decision Algorithm to Define the Preservation/Ligation of an Aberrant Left Hepatic Artery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05971069
• Other study ID #: 3-2021-0376
• Status: Completed
• Phase: N/A
• Start date: December 17, 2021
• Est. completion date: June 12, 2023

Study information

• Verified date: July 2023
• Source: Gangnam Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

" Hepatic artery variants are occasionally seen, especially 20-30% of aberrant left hepatic artery. In radical gastrectomy, decision for aberrant left hepatic artery(ALHA) ligation should consider the oncologic safety and liver-related complication. Theoretically, the ALHA preservation is the most ideal in the aspect of liver function protection. However, it is technically difficult which consumes much time. Not only that, oncologic safety could be threatened as some soft tissues, including lymph nodes, could be remained while in preserving the ALHA.

There has been no standardized method to evaluate the ALHA, and to decide whether preserve or ligate it.

This prospective study has been designed to develop the decision algorithm to define the ALHA preservation/ligation, using near-infrared fluorescence imaging during surgery. "

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 12, 2023
• Est. primary completion date: June 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Patients diagnosed with gastric adenocarcinoma pathologically before surgery

2. Patients aged between 20 to 80

3. Patients with an ECOG 0 or 1

4. Patients who were confirmed the presence of aberrant left hepatic artery before or during surgery

Exclusion Criteria:

1. Patients with abnormal liver function test befor surgery

2. Patients who diagnosed liver cirrhosis or infectious liver disease

3. Patients who underwent liver resection, or chemotherapy for gastric cancer

4. Patients planned for combined liver resection or cholecystectomy during gastrectomy

Related Conditions & MeSH terms

• Stomach Neoplasm
• Stomach Neoplasms

Intervention

Procedure:
• Group1
Entire fluorescence defect on the Lt. lobe of liver ? Preservation of the aberrant left hepatic artery
• Group2
Partial fluorecence defect on the Lt. lobe of liver ? Ligation of the aberrant left hepatic artery
• Group3
No fluorescence defect on the Lt. lobe of liver ? Ligation of the aberrant left hepatic artery

Locations

Country	Name	City	State
Korea, Republic of	GangnamSeverance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The safety and efficacy of the decision algorithm for the aberrant left hepatic artery preservation/ligation with real time near-infrared fluorescence imaging	Investigator discretionally designed the decision algorithm for aberrant left hepatic artery preservation/ligation with real time near-infrared fluorescence imaging.; The order of the algorithm is as follows: First, when surgeons identify the aberrant left hepatic artery during surgery, clamping the artery and injectioning indocyanine green (5mg/mL) intravenously would be performed.; After that, in a few seconds, liver perfusion could be detected through real time near-infrared fluorescence imaging.; The ligation or preservation of the aberrant left hepatic artery would be decided according to the proportion of the near-infrared fluorescence imaging defect. Investigator's like to confirm the safety and efficacity of this decision algorithm.	Real time near-infrared fluorescence image will be obtained during the surgery.
Secondary	Number of participants with liver-related postoperative complications as assessed by serum aspartate transaminase(AST) and alanine transferase(ALT)	The elevated proprtion of the serum aspartate transaminase(AST, IU/L) and alanine transferase(ALT, IU/L) compared to preoperative value will be calculated and compared by groups.	Serum aspartate transaminase(AST, IU/L) and alanine transferase(ALT, IU/L) will be estimated in postoperative 1st, 2nd, 3rd and 5th day.